On April 29, the FDA approved a 10-g pharmacy bulk vial of sterile vancomycin HCl injection (Hospira, Inc).
"This approval means Hospira now offers the most complete product portfolio of this important drug, which is an effective agent for fighting methicillin-resistant Staphylococcus aureus (MRSA)," the company said in a news release, noting that MRSA infections are often resistant to other antibiotics.
The glycopeptide antibiotic previously was approved in 500-mg, 750-mg, and 1-g dosages; and in 5-g pharmacy bulk packages.
Vancomycin is indicated for the treatment of serious, life-threatening infections by gram-positive bacteria that are unresponsive to other less toxic antibiotics.
To control the spread of vancomycin resistance, the Centers for Disease Control and Prevention advises that vancomycin therapy be restricted to the treatment of serious infections caused by susceptible organisms resistant to penicillins, pseudomembranous colitis refractory to metronidazole, infections caused by gram-positive microorganisms in patients with severe allergies to beta-lactam antimicrobials, antibacterial prophylaxis for endocarditis after certain procedures in penicillin-hypersensitive individuals at high risk, and as surgical prophylaxis for major procedures involving implantation of prostheses in institutions having a high rate of MRSA or methicillin-resistant S epidermidis.